Definition: A new dietary ingredient (NDI) is a dietary ingredient that was not marketed in the United States before October 15, 1994 (21 U.S.C. 350b). In many cases a company must send FDA safety evidence at least 75 days before selling a supplement that contains one.
The notice is required unless the ingredient has been in the food supply as an article used for food in a form that has not been chemically altered. Under 21 CFR 190.6 the notice must include:
The product may not be sold for 75 days after FDA receives the notice, and a substantive update can reset that clock. FDA keeps the notice private for 90 days, then posts it publicly, minus trade secrets. The rule says plainly that if FDA does not respond, that is not a finding that the ingredient or product is safe.
The law also says FDA must tell the Drug Enforcement Administration if a notice is inadequate because the ingredient may be an anabolic steroid or an analogue of one.
An NDI notice is a company filing, not an approval. A newer ingredient may have only the evidence in that notice behind it. Keeping the exact product name and lot in your log makes it easier to look up later.
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